Dr Victoria Shepherd

Publication

• Date
• Type

Research

Research overview

My research seeks to improve the inclusion of under-served groups in research with a particular focus on populations where there may be additional challenges around informed consent. My work primarily focuses on exploring the ethical and methodological challenges around the inclusion of adults lacking capacity in research and developing and evaluating interventions to support inclusion. I also concurrently implement this work in a range of clinical trials through leading embedded methodological research to explore and address the barriers encountered in particular contexts. My work is widely cited in guidance for researchers and by organisations such as research funders and governance organisations.

Adults with impaired capacity to consent

I currently hold an NIHR Advanced Fellowship 'Deciding about research for others: a feasibility study and effectiveness trial of a novel decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT)' (2021-2026). The intervention (a decision support tool to enhance proxy decision-making for research will be evaluated using a 'Study Within A Trial' (SWAT) design to embed the evaluation in up to 5 host trials. Outputs from CONSULT can be found on the project website (www.capacityconsentresearch.com) alongside collated information and resources.

As part of the CONSULT project, I led a qualitative study exploring researchers and healthcare professionals' views about the barriers and facilitators to conducting trials involving adults lacking capacity to consent (CONSULT-ENABLE Study). I am also leading the CONSULT-ADVANCE Study to explore stakeholders' views about the feasibility and acceptability of advance research planning, which is a process for people to express their wishes about research participation in advance of any loss of capacity to consent. The survey and qualitative interview study have been completed and published, with further work planned. I also hold a Churchill Fellowship to explore international perspectives on advance planning for research with visits to Canada and Australia in 2024.

I led the development of a core outcome set to evaluate interventions that enhance proxy decisions about participation on behalf of adults who lack capacity (COnSiDER Study) which is registered on the COMET database (#1409). Alongside this, I developed a new outcome measure to assess the quality of decisions made about research on behalf of someone who lacks capacity to consent - the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale).

I also led the development of the NIHR INCLUDE Impaired Capacity to Consent Framework which is a tool to help researchers to design trials involving adults with impaired capacity to consent. An implementation toolkit is being developed as part of a project supported by 'Innovation for All' funding from Cardiff University (2022-2023). I am now leading a project to develop stakeholder-informed CONSULT training for researchers on the design and conduct of trials involving adults with impaired capacity to consent.

I previously held an NIHR Doctoral Research Fellowship to explore the ethical, legal and practical challenges around the inclusion of these under-represented populations, using mixed-methods and interdisciplinary approaches (2016-2019). I led a follow on study to conduct cognitive testing of the decision support intervention (DECISION 2 Study) funded by the Wellcome Trust through ISSF Institutional Funding (2020).

I supervise a number of Intercalated BSc medical students and PhD projects in this area, and recently curated research and resources on 'Research and capacity to consent' for Social Care Wales.

Clinical Trials

I am leading a 'Study Within A project' (SWAP) which is a methodological study embedded with a trial to evaluate the clinical and cost effectiveness of a co-designed individualised osteo-arthritis self-management support intervention for promoting health related quality of life and reducing healthcare costs (TIPTOE) (2023-2026). The embedded SWAP will explore and address the recruitment and retention of underserved groups in the trial and identify barriers to their inclusion. I also lead a second SWAP exploring the inclusion of under-served groups (including frailer older people) in a trial of adjuvant radiotherapy in patients with high-risk primary cutaneous squamous cell carcinoma after surgery (SCC-AFTER) (2023-2030), alongside a QUINTET Recruitment Intervention (QRI+INCLUSION SWAP).

Previous research activities include contributing to the design, delivery and reporting of multicentre randomised controlled trials, including: Children with Eczema, Antibiotic Management - CREAM Study (NIHR HTA), Oral STeroids for the Resolution of otitis media with effusion (OME) In Children – OSTRICH Study (NIHR HTA) and Probiotics to Reduce Infections iN CarE home reSidentS – PRINCESS Study (NIHR EME).

Care Homes

I have a special interest in care home research. I led a UK wide Research Priority Setting in Care Homes Study, which aimed to identify a set of research priorities for care home research with a key group of stakeholders, and a current core outcome set for the prevention of COVID-19 in care homes (COS COVID PCARE). I am also involved in collaborating with other national and international researchers/institutions to develop research proposals involving older people in long term care, some of which address areas identified as research priorities.

I am co-applicant on a project developing self-management support training for carers of older adults with osteoarthritis and additional conditions (SUSTAIN), and a project to explore the implementarion of the Mental Capacity Act in care homes (ENACT).

Trials Methodology Research

I am interested in research to improve the conduct of trials, with a particular focus on improving inclusivity of under-served populations in research. I co-lead the inclusivity theme of the Trial Conduct Working Group of the MRC-NIHR Trials Methodology Research Partnership and the Complex & Alternate Consent Pathways Group.

Research Ethics

I am involved in a number of projects exploring ethical aspects of research, including models of consent used in different research contexts such as the use of advanced consent in emergency situations.

Funding and grants

2024

• Planning ahead: communicating preferences about research through advance research planning. Churchill Fellowship (Lead applicant) (2024)
• No Voice, No Choice? Reducing system factors that form a barrier to research for those with impaired capacity nearing the end of life across care settings. NHS England, Research Engagement Network funding (Co-applicant) (2024 – 2025)
• Feasibility of Advance Consent for ParticipaTION in Acute Stroke Trials (ACTION). Canadian Institutes of Health Research project grant (Co-applicant) (2024 – 2025)
• EXamining antibiotics for ulCerated skIn cancer Surgical Excision (EXCISE) NIHR Health Technology Assessment Programme project grant (Co-applicant) (2025-2027)

202

• Development of stakeholder-informed training for researchers designing and conducting trials involving adults with impaired capacity to consent. UKRI Impact Accelerator Fund (Lead applicant) (2023 - 2024)
• MulTI-domain Selfmanagement in Older People wiTh OstEoarthritis and Multi- Morbidities (TIPTOE). NIHR Health Technology Assessment Programme (Co-applicant) (2023 - 2026)
• Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE). NIHR Research for Patient Benefit (Co-applicant) (2023 - 2024)
• Adjuvant radiotherapy in patients with high-risk primary cutaneous Squamous Cell Carcinoma AFTER surgery (SCC-AFTER): an open label, multicentre, two-arm phase III randomised trial. NIHR Health Technology Assessment Programme project grant (Co-applicant) (2023 - 2030)
• No research about us, without us! Removing research barriers for people with learning disabilities. NIHR Programme Grant for Applied Research Programme Development Grant (Co-applicant) (2023 – 2024)
• Adult Social Care Centre (CARE). Health and Care Research Wales infrastructure award (Co-applicant) (2023 - 2028)
• Evaluating staff training and the implementation of the Mental Capacity Act in care homes for older adults (ENACT). NIHR Health and Social Care Delivery Research (HSDR) project grant (Co-applicant) (2023 – 2026)
• Health Data Research UK: Tools for Trials. HDR UK infrastructure award (Co-applicant) (2023 - 2028)

2022

• Implementation of the of the ‘INCLUDE Impaired Capacity to Consent Framework’ for researchers. Innovation for All Programme, Cardiff University (Lead applicant) (2022 - 2023)
• Deciding about research for others: a feasibility study and effectiveness trial of a novel decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT). NIHR Advanced Fellowship (funded by Health and Care Research Wales) (Lead applicant) (2021 - 2026)
• Self-management support training for carers of older adults with osteoarthritis and additional conditions living in care homes (SUSTAIN). UKRI Economic and Social Research Council. Health Ageing Catalyst (Co-applicant) (2022 - 2023)
• Engaging care home residents in research: identification of barriers and facilitators and the development of an intervention to support residents in decision-making and advance planning for research (ENGAGE). Health and Care Research Wales. Social Care PhD Studentship (Co-lead applicant) (2022 - 2024)

2021

• A collaborative study between CTUs to identify the activity and resource needed to improve representation of under-served groups in trials (ACCESS). NIHR CTU Support Funding (Co-applicant) (2021 - 2023)

2020

• Proxy decision-making for research involving adults who lack capacity to consent: cognitive testing of a novel decision support intervention and establishing a core outcome measurement set. Wellcome Trust Institutional Strategic Support Fund Consolidator Award (Lead applicant) (2020 - 2020)
• Informed consent and proxy decision making in research involving adults lacking capacity: development of an intervention to support proxy informed decision making, set within ethical and legal frameworks. NIHR Doctoral Research Fellowship (funded by Health and Care Research Wales) (Lead applicant) (2016 - 2019)

Biography

Honours and awards

NHS 75 Faces of Nursing Research (2024)

Churchill Fellowship (2023)

Wales Nurse of the Year Awards - Supporting Improvement Through Research Award (runner up, 2019)

PhD Deciding about research for others: normative, empirical, and legal accounts of proxy decision-making for research and the development of a decision support intervention (November 2019)

BSc Acute and Critical Care, MA Healthcare Law and Ethics. Dissertation: Vulnerable populations in medical research: is research regulation ‘protecting them to death'? (September 2014)

Professional memberships

NMC (Nursing and Midwifery Council)

Institute of Medical Ethics

RCN Wales Nurse of the Year Alumni Network

Committees and reviewing

Member of fellowship funding panels - FWO (Belgium), NIHR, Health and Care Research Wales

Member of NHS Research Ethics Committee (2019-present)

Chair of ENRICH Cymru Advisory Group (2021-present)

Consultant Editor in clinical trials & care homes studies for Geriatrics, Gerontology and Aging (March 2020-present)

Journal reviewer (e.g Trials, Age and Ageing, Nurse Education in Practice)

Grant reviewer (e.g NIHR, Health and Care Research Wales, Dunhill Medical Trust)

Supervisions

I am interested in supervising PhD students in the areas of:

• trials methodology research focusing on the inclusion of under-served groups
• ethical and legal issues in research involving populations where there may be challenges around capacity to consent
• care homes and care home research
• nursing with a particular focus on critical care and the care of older people

Current PhD supervision:

Title: Engaging care home residents in research: identification of barriers and facilitators and the development of an intervention to support residents in decision-making and advance planning for research (ENGAGE)

PhD student: Brittany Nocivelli

Supervision team: Prof Fiona Wood, Dr Victoria Shepherd, Prof Kerry Hood, Prof Carolyn Wallace

This mixed-methods PhD project aims to explore how care home residents and their carers can be better engaged in research, and the barriers and facilitators to their inclusion. Using established intervention development methods, an intervention will be developed to support conversations about research with care home residents and facilitate advance planning for research participation. The findings will support opportunities for care home residents to participate in research, have their voices heard, and receive quality evidence-based care in the future. It is funded through a Health and Care Research Wales Social Care PhD studentship (2021-2024).

Further details: https://healthandcareresearchwales.org/researchers/our-funded-projects/engaging-care-home-residents-research-identification-barriers-and

Title: Making it easier for trial teams to design inclusive trials

PhD student: Azar Alexander-Sefre

Supervision team: Prof Shaun Treweek, Dr Heidi Gardner, Dr Victoria Shepherd, Dr Frances Sherratt

Trial participants need to represent those in society who are intended to benefit from the outcomes of the trial. The groups needing representation most will vary from trial to trial. An under-served group for one type of trial may be very different to that of another. Reasons for why under-served groups are not included in some research can be complex, but solutions to resolve inclusion barriers are easier to determine if considered from the outset of a trial. Intersectionality goes a step further in recognising that there may be multiple factors (for example ethnicity and gender) that combine and lead to disadvantage or discrimination. A few tools have recently been developed called the INCLUDE Frameworks (see https://www.trialforge.org/trial-forge-centre/diversity/) to help trial teams to think about how their design decisions might make it easy or difficult for some groups to take part.The goal of this mixed-methods PhD project is to provide trial teams with a streamlined process to efficiently navigate their way through the Frameworks. To do this, we will firstly need to determine where intersectionality between different under-served groups exist and what this means for researchers who will need to consider these groups when designing their trials. Additionally, the project will consider what kinds of prompts can enable researchers to effectively delve into the barriers and challenges that these intersectional populations may have with participation. Finally, the project will investigate what kinds of solutions researchers could be given to make sure that these critical Framework questions are not only asked but actioned, to ensure their trials are truly inclusive in practice. It is funded through an MRC TMRP DTP Studentship at the University of Aberdeen (2022-2025).

Further details: https://www.abdn.ac.uk/hsru/what-we-do/research/projects/making-it-easier-for-trial-teams-to-design-inclusive-trials-341

Named Supervisor on GW4 Clinical Academic Training Programme for Health Professionals (GW4-CAT HP)

Current supervision

Brittany Nocivelli

Research student